Medtech Security

Medical devices, healthcare applications, and connected clinical systems are becoming increasingly software-driven and integrated with external services. At the same time, regulatory expectations continue to rise. MDR, IVDR, FDA guidance, HIPAA, and standards such as IEC 62304 and IEC 62443 place strict requirements on cybersecurity throughout a product’s lifecycle—from design and development to deployment and maintenance.

Our security specialists have extensive experience testing medical technology, healthcare apps, cloud platforms, and embedded systems. We understand the challenges of securing safety-critical devices and clinical workflows, and we know how to assess medtech systems safely and effectively.

Security for Medical Devices and Healthcare Systems

We perform security assessments across the medtech ecosystem, including medical devices, companion apps, backend systems, hospital networks, and cloud-hosted healthcare services. Our work includes penetration testing aligned with FDA cybersecurity expectations and EU regulatory requirements.

We test:

Medical devices and embedded systems, including implantable, wearable, diagnostic, and therapeutic devices
Healthcare applications, such as mobile health apps, patient portals, web systems, and clinician-facing tools
Connected ecosystems, including cloud APIs, telemedicine platforms, and integration with EHR/EMR systems
IoMT and healthcare network environments, where devices communicate over hospital infrastructure
Firmware, communication protocols, wireless interfaces, and update mechanisms (including OTA updates)

Our testing identifies architectural weaknesses, insecure endpoints, unsafe communication paths, lack of encryption or authentication, and vulnerabilities in code, firmware, or app design. All engagements are conducted with careful attention to patient safety, data integrity, and regulatory constraints.

Penetration Testing for Regulatory Compliance

We perform penetration testing aligned with key regulatory frameworks:

EU MDR and IVDR requirements for security risk management
FDA cybersecurity expectations for medical device submissions
IEC 62304 for secure software lifecycle processes
IEC 62443 applied to healthcare environments and connected device ecosystems
HIPAA obligations for safeguarding health information

Our assessments include:

Threat modeling and TARA-style risk analysis
Vulnerability discovery in apps, devices, APIs, and firmware
Secure update mechanism testing (OTA and wired)
Cryptography and certificate management review
Wireless security testing (Bluetooth, BLE, Wi-Fi, NFC)
Authentication/authorization and privilege escalation testing
Validation of secure software processes for compliance documentation

Our results are adapted to integrate directly into your cybersecurity documentation, as well as premarket submissions, and post-market surveillance requirements.

Healthcare App and Cloud Security Testing

Modern medtech products rely on mobile apps, patient portals, and cloud services. We test:

iOS and Android apps used by patients, clinicians, or technicians
Web portals and dashboards for monitoring, configuration, and reporting
Cloud APIs and backend infrastructure
Data flows involving PHI/PII, ensuring compliance with HIPAA and GDPR

Our testing evaluates authentication flows, API protection, session management, data integrity, backend access controls, and communication security.

If you are not ready for a full penetration test, we recommend a targeted security assessment to identify immediate risks and prepare for certification or regulatory review.

Secure Design and Development

Cybersecurity must be integrated early in the development process. We provide advisory support for:

Secure architecture and threat modeling
Vendor and supply-chain risk assessments
Software lifecycle compliance (IEC 62304)
Security controls required by MDR/IVDR and FDA premarket submissions
Risk mitigation strategies aligned with IEC 62443
Code review and development pipeline hardening

We bridge the gap between engineering, regulatory requirements, and cybersecurity best practices.

Real-World Experience

We have hands-on experience securing:

Connected medical devices and embedded systems
Hospital networked appliances
mHealth apps
Telemedicine platforms and cloud-based diagnostic services
IoMT deployments in clinical settings

Our specialists are trained to work in sensitive environments where safety, data integrity, and regulatory compliance are critical.

Awareness and Training

Securing medtech environments requires knowledgeable engineering and clinical teams. We offer custom training sessions and workshops covering:

Threat modeling for medical devices
Secure design and coding practices
Architecting healthcare systems securely

Training can be tailored for developers, product managers, QA teams, and regulatory professionals.

Advisory and Compliance Support

We assist organizations preparing for certification, regulatory submissions, and internal audits. Our advisory services support, among other areas:

IEC 62304 software lifecycle implementation
IEC 62443 security controls for connected systems
MDR/IVDR technical documentation
FDA premarket submission cybersecurity sections
Post-market cybersecurity processes and vulnerability management

Whether you are designing a new medical device or securing an existing product line, we can help ensure your security meets both regulatory and real-world expectations.